CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report
Noblus AC Adapter used with the Noblus Ultrasound Imaging System recalled
Fujifilm Healthcare Americas is recalling Noblus AC Adapter used with the Noblus Ultrasound Imaging System, distributed nationwide in the US. The recall was initiated on 11 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1884-2024
- FDA event ID
- 94441
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Apr 2024
- FDA classified
- 22 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 11 Apr 2024 | Recall initiated by company | |
| 22 May 2024 | Classified by FDA | +41 days |
| 29 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Product as listed by the FDA
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Which lots are affected?
UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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